FDA 510(k) Application Details - K200093

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K200093
Device Name	Polymer Patient Examination Glove
Applicant	Anhui lntco Medical Products Co., Ltd. No. 1 Haitang Road, Suixi District Economic Development Area Huaibei City 235100 CN Other 510(k) Applications for this Company
Contact	Jacken Cai Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2020
Decision Date	08/20/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review